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Brain and Nervous SystemPhase 1NCT05474378

B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme

A Phase 1 study testing B7-H3CART in people with Brain and Nervous System, run by Stanford University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is an open label, non-randomized, single site Phase I study to test the manufacturing feasibility and safety of locoregional (LR) administration of B7-H3CART into the central nervous system of adult subjects with recurrent IDH wild-type GBM using a standard 3+3 dose escalation design. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Nervous System
What is being tested?
B7-H3CART
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
12 Jul 2022to Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed high grade (WHO Grade IV) glioma including but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial features, glioblastoma with PNET features, tested as IDH wild-type, as per revised WHO 2021 criteria. Patients must also have evidence of tumor recurrence/progression by MRI (RANO criteria) after standard front-line therapy. b. First recurrence or progressive disease after a standard line therapy.
  • Resectable disease: Resection is being considered as part of the standard of care for the patient and it is thought that it is feasible that a majority of contrast-enhancing tumor mass/signal can be resected.
  • Patients must be between the ages of 18 and 75 years old (inclusive).
  • Karnofsky Performance score ≥ 60.
  • Use of steroids must be limited to ≤ 4 mg of decadron daily.
  • Adequate organ function at time of screening visit including:
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  • Hgb ≥ 12 g/dL (male) or ≥ 11.5 g/dL (females)
  • ANC ≥ 1500/uL
  • Platelets ≥ 100,000/uL
  • Absolute lymphocyte count ≥150/uL
  • Serum Creatinine ≤ 1.5mg/dl; Cr clearance should be ≥ 50 mL/min
  • Serum AST and ALT ≤ 3x ULN (Grade 1)
  • Total Bilirubin ≤ 1.5 X ULN
  • PT or PTT ≤ 1.25 X ULN
  • Cardiac ejection fraction ≥45% without signs of physiologically significant pericardial effusion or clinically significant ECG findings.
  • Baseline oxygen saturation > 92% on room air
  • Subjects of child-bearing or child-fathering potential must be willing to use an effective method of contraception (hormonal or two barrier methods) while on study and for at least 4 months following the last CAR T cell infusion or as long as B7-H3CART are detectable in peripheral blood or CSF.
  • All female subjects of childbearing age must have a negative blood or urine pregnancy test.
  • Ability to understand and willingness to sign a written informed consent document.
  • Must be willing and able to comply with procedures, return visits and evaluations at Stanford Health Care while on this protocol.
  • Prior Therapy:
  • At least 6 weeks following completion of front-line radiation therapy.
  • At least 3 weeks post chemotherapy or 5 half-lives, whichever is shorter must have elapsed since any prior systemic therapy, except for systemic inhibitory/stimulatory immune checkpoint therapy, which requires 5 half-lives.
  • At least 4 weeks from bevacizumab treatment, which can be used only for radiation necrosis or pseudo-progression.
  • Prior cytotoxic chemotherapy, radiation, or other anticancer therapies including investigational agents discontinued at least 4 weeks prior to Day 1 of treatment.
  • Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia).

Who cannot join

  • Pregnant or patients who are breastfeeding.
  • Prior or concurrent treatment with Avastin (bevacizumab) for the purposes of recurrent disease. Avastin (bevacizumab) may have been used for radiation necrosis.
  • Prior exposure to chimeric antigen receptor (CAR) based therapies.
  • Known sensitivity or allergy to any agents/reagents used in this study.
  • Requires current anticoagulation therapy that cannot be safely paused for surgical resection and Ommaya access.
  • Prior malignancy except previously diagnosed and definitively treated more than 3 years prior to trial or whose prognosis is deemed good enough to not warrant surveillance.
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  • Clinical evidence of significant increased intracranial pressure (i.e. impending herniation) or uncontrolled seizures.
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
  • Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
  • Primary immunodeficiency or history of autoimmune disease (e.g. Crohn's, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
  • Significant medical diseases or conditions, including poorly controlled conditions: i.e. hypertension, cardiovascular disease, diabetes mellitus, chronic obstructive pulmonary disease, pulmonary fibrosis, inflammatory disorders, immunodeficiency (e.g., HIV infection), immune compromised for reasons other than malignancy (e.g., chronic corticosteroid therapy or other immunosuppressive therapy), renal failure including patients requiring dialysis, liver dysfunction, second malignancy (except treated basal cell or localized squamous cell skin carcinomas), or active infection.
  • History of bone marrow or stem cell transplantation.
  • In the investigator's judgment, the subject is unlikely to complete all protocol- required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kelly Tanner contact

650-724-5361

ketanner@stanford.edu

United States1 site, 1 recruiting

  • Stanford Cancer Institute

    Palo Alto, California, 94305

    Kelly Tanner, 650-724-5361, ketanner@stanford.edu

    Gordon Li, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase I Clinical Trial of Locoregionally (LR) Delivered Autologous B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Adults With Recurrent Glioblastoma Multiforme (GBM)

This is an open label, non-randomized, single site Phase I study to test the manufacturing feasibility and safety of locoregional (LR) administration of B7-H3CART into the central nervous system of adult subjects with recurrent IDH wild-type GBM using a standard 3+3 dose escalation design.

Being tested
B7-H3CART
Medical subject headings
Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B7-H3CARTDrug

    Also called B7H3-CAR T

    B7-H3CART will be administered administered locoregionally (either ICV or both ICV and intratumorally (IT)) at one of the following doses:

    Dose Level -1: 5 x 10^6 CAR+ cells (+/- 20%) Dose Level 1: 10 x 10^6 CAR+ cells (+/- 20%) Dose Level 2: 25 x 10^6 CAR+ cells (+/- 20%) Dose Level 3: 50 x 10^6 CAR+ cells (+/- 20%) Dose Level 4: 100 x 10^6 CAR+ cells (+/- 20%)

    B7-H3CART Dose Dose Level -1 (DL-1): 5 x 106 B7-H3CART+ cells (± 20%) Dose Level 1 (DL 1): 10 x 106 B7-H3CART+ cells (± 20%) Dose Level 2 (DL2): 25 x 106 B7-H3CART+ cells (± 20%) Dose Level 3 (DL3): 50 x 106 B7-H3CART+ cells (± 20%) Dose Level 4 (DL4): 100 x 106 B7-H3CART+ cells (± 20%)

    Repeated every 28 days (-7 / +14 days) as long as infusion criteria are met for a total of 6 doses, with an option for an additional 6 doses, up to a total of 12.

Study groups in NCT05474378
Study groupRoleWhat they receive
Dose escalationExperimentalAll subjects will be assigned to a dose level. Does escalation will proceed sequentially via a standard 3+3 dose escalation design in subjects who receive at least one infusion of B7-H3CART. Each dose level will include 3 to 6 subjects, starting at Dose Level 1. If Dose Level 1 is considered too toxic, the dose may be de-escalated to Dose Level -1. If Dose Level 4 is completed with no dose limiting toxicity (DLT) in six subjects, a maximum tolerated dose (MTD) may not be determined, and Dose Level 4 will instead be the maximum administered dose (MAD). T
Receives: Drug: B7-H3CART
Dose ExpansionExperimentalAfter Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) is established, a total of 12 evaluable subjects (including the 6 subjects infused during the dose escalation phase) will be enrolled at the RP2D to further explore safety of repeat administrations at MTD/RP2D and conduct a preliminary assessment of benefit.
Receives: Drug: B7-H3CART

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of successful manufacturing product (B7-H3CART) that met minimum assigned dose level range

    Defined by the frequency of successful manufacturing runs of B7-H3CART that meet the established IND release criteria for the targeted dose level.

    Measured: 5 years

  2. Maximum Tolerated Dose (MTD) or Recommended phase 2 dose (RP2D)

    Defined by the frequency of subjects experiencing dose limiting toxicity (DLT) after initial infusion

    Measured: 5 years

Secondary outcomes (5)

  1. Cumulative Safety of B7-H3CART

    At each dose level, incidence and severity of DLT, adverse events and serious adverse events after initial and subsequent infusions of LR B7-H3CART infusion. The definition of DLT in these studies uses NCI's Common Terminology Criteria for Adverse Events (CTCAEv5.0)

    Measured: 5 years

  2. Immunotherapy Response Assessment in Neuro-oncology (iRANO) in subjects with recurrent IDH wild-type GBM

    iRano response criteria will be measured by complete response, partial response, minor response, stable disease, progressive disease,

    Measured: 5 years

  3. Time to progression (TTP)

    the time from the start (surgical resection) to the date of radiographic progression (death is censored)

    Measured: 5 years

  4. Median overall survival (OS)

    time from the date of initial disease diagnosis to the date of death from any cause

    Measured: 5 years

  5. Percentage of subjects able to receive at least three (3) doses of B7-H3CART

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start12 Jul 2022
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05474378
Sponsor's protocol ID
IRB-65002
Other IDs
NCI-2022-06043
Status last verified
Sep 2026
First submitted
22 Jul 2022
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing B7-H3CART in people with Brain and Nervous System, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kelly Tanner (650-724-5361, ketanner@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of successful manufacturing product (B7-H3CART) that met minimum assigned dose level range (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05474378.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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